Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Siemens Medical Solutions Diagnostics, AIMC 23-01, Atellica IM Free Prostate-Specific Antigen fPSA

   The purpose of this communication is to inform you of an issue with the product indicated in Table 1 above and provide ...

   Waarschuwing | 07-12-2022

2. The Binding Site Group Limited, FSN-AE061, Freelite® Human Lambda Free Kit for use on the Siemens BN ProSpec®

   Na een aantal meldingen van klanten en interne tests hebben we vastgesteld dat de kit vermeld in tabel 1 de optische limiet van ...

   Waarschuwing | 03-11-2022

3. Siemens Healthcare Diagnostics Inc, FSN-ACHC 22-07, Atellica CH Lithium_2 (LITH_2); Atellica CH Lithium (Li)

   Siemens Healthcare Diagnostics Inc. has confirmed customer complaints indicating the potential for falsely elevated LITH_2 and Li ...

   Waarschuwing | 11-10-2022

4. Actim Oy, 725, Actim 1ngeni

   It is possible that in some rare cases when the IGFBP-1 concentration in the sample is near the cut-off of the test, the Actim ...

   Waarschuwing | 27-09-2022

5. DiaMed GmbH, FSN-FSCA 002-22, IH-QC8

   Following two customer complaints, it has been confirmed that tubes from the impacted lot may present clots of red blood cells ...

   Waarschuwing | 27-09-2022

6. Biomedical Data Solutions, 73555, Ortho Connect

   When Cancelling an Edit during Result Review, Approved results are incorrectly saved using the cancelled data.  

   Waarschuwing | 07-09-2022

7. Actim Oy FSCA 471 - Actim Partus 1ngeni

   Our long-term stability testing has shown that the quantitative results of Actim Partus 1ngeni do not fulfill the acceptance ...

   Waarschuwing | 02-06-2022

8. Abbott Laboratories, FSN-FA28APR2022_06P16-01, Alinity s System

   Abbott has identified a potential issue with Alinity s System software versions 2.8.0 and prior. Abbott is releasing Alinity s ...

   Waarschuwing | 20-05-2022

9. Ortho Clinical Diagnostics CL2022-099 - ORTHO VISION and VISION Max Analyzers

   Ortho Clinical Diagnostics received complaints in which customers obtained unexpected results on their ORTHO VISION analyzer. ...

   Waarschuwing | 18-05-2022

10. Ortho Clinical Diagnostics CL2022-094 - ORTHO Optix Reader

    Ortho Clinical Diagnostics received a complaint regarding an incorrectly displayed passing QC status for a test (see example in ...

    Waarschuwing | 18-05-2022